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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device suture, recombinant technology
Regulation Description Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.
Definition Intended for use in soft tissue approximation. Indicated for use in general soft tissue approximation and/or ligation.
Product CodeNWJ
Regulation Number 878.4494
Device Class 2


Premarket Reviews
ManufacturerDecision
TEPHA, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 7 7
2023 4 4
2024 1 1
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 7 7
Difficult to Open or Remove Packaging Material 3 3
Detachment of Device or Device Component 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Packaging Problem 2 2
Fracture 2 2
Melted 2 2
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17 17
Insufficient Information 1 1

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